High-risk Biochemical Recurrence, High Risk Biochemical Recurrence of Non-metastatic Castration-sensitive Prostate Cancer, Non-metastatic Castration-sensitive Prostate Cancer, Prostate Cancer
Conditions
Keywords
Xaluritamig, T-Cell Engager, AMG509, STEAP1, Immunotherapy
Brief summary
The main objective of this study is to evaluate the safety and tolerability of xaluritamig monotherapy in adult participants with high-risk biochemical recurrent (BCR) nonmetastatic castration-sensitive prostate cancer (nmCSPC).
Interventions
DRUGXaluritamig
IV infusion
Sponsors
Amgen
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically or cytologically confirmed adenocarcinoma of the prostate at initial biopsy, without neuroendocrine differentiation, signet cell, or small cell features. * Prostate cancer initially treated by radical prostatectomy (RP) or radiotherapy (XRT) (including brachytherapy) or both (eg, salvage radiotherapy), with curative intent. * PSA doubling time ≤ 12 months. * Participants must have biochemically recurrent disease after definitive treatment to prostate by either RP or XRT. * Screening PSA by the local laboratory ≥ 0.2 ng/mL for participants who had RP (with or without XRT) as primary treatment for prostate cancer or at least 2 ng/mL above the nadir (local assessments) for participants who had XRT or brachytherapy only as primary treatment for prostate cancer. * Serum testosterone ≥ 150 ng/dL (5.2 nmol/L). * Participants must have undergone a prostate-specific membrane antigen (PSMA) positron emission tomography (PET) scan during or within 3 months of screening.
Exclusion criteria
* Present evidence of metastatic disease in conventional CT scan and/or bone scan * Participants that present PSMA-positive lesions in the PSMA PET scan may be enrolled if the conventional imaging does not show suspicion of metastatic disease. * Prior hormonal therapy, exceptions include: * Neoadjuvant/adjuvant therapy to treat prostate cancer ≤ 36 months in duration and ≥ 9 months before enrollment, or * A single dose or a short course (≤ 6 months) of hormonal therapy given for rising PSA ≥ 9 months before enrollment. * Prior cytotoxic chemotherapy, aminoglutethimide, ketoconazole, abiraterone acetate, enzalutamide, apalutamide, or darolutamide for prostate cancer. * Abiraterone acetate, enzalutamide, apalutamide, or darolutamide are allowed if administered in a neoadjuvant/adjuvant setting ≤ 36 months in duration and ≥ 9 months before enrollment. * Prior systemic biologic therapy, including immunotherapy, for prostate cancer. * If, in the investigator's opinion, salvage therapy is the preferred intervention. * Autoimmune disease requiring systemic immunosuppression within the past 2 years. * Participant with symptoms and/or clinical signs and/or radiographic signs that indicate an acute and/or uncontrolled active systemic infection within 7 days prior to the first dose of study treatment. * Requirement for chronic systemic corticosteroid therapy (prednisone dose \> 10 mg/day or equivalent) or any other immunosuppressive therapies (including anti tumor necrosis factor alpha \[TNFα\] therapies) unless stopped (with adequate tapering) within 7 days prior to dosing.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) | Up to approximately 2 years | Events categorized as adverse events (AEs) starting on or after first dose of investigational product (xaluritamig) as determined by the flag indicating if the AE started prior to the first dose on the Events Electronic Case Report Form (eCRF) and including 30 days after the last dose of investigational product (xaluritamig) or end of study date, whichever is earlier. |
| Number of Participants Experiencing Treatment-related Adverse Events (TRAEs) | Up to approximately 2 years | A TRAE is any TEAE that per investigators' review has a reasonable possibility of being caused by the investigational product (xaluritamig) determined by the flag indicating an event may have been caused by the investigational product (xaluritamig) on the Events eCRF. In the unlikely event that the flag is missing, the TEAE will be considered related. |
Secondary
| Measure | Time frame |
|---|---|
| Time to Prostate-specific Antigen (PSA) Progression | Up to 50 months |
| Number of Participants With a PSA 50 Response | Up to approximately 50 months |
| Number of Participants With a PSA 90 Response | Up to approximately 50 months |
| Duration of PSA 50 Response | Up to approximately 50 months |
| Duration of PSA 90 Response | Up to approximately 50 months |
| Number of Participants With Undetectable PSA | Up to approximately 50 months |
| Time to Initiation of Androgen Deprivation Therapy or Androgen Receptor Directed Therapy | Up to approximately 50 months |
| Time to First use of new Anticancer Therapy | Up to approximately 50 months |
| Time to Metastatic Disease/Progression | Up to approximately 50 months |
| Metastasis-free Survival (MFS) | Up to approximately 50 months |
| Number of Participants Completing Xaluritamig Monotherapy Treatment | Up to approximately 24 months |
| Maximum Serum Concentration (Cmax) of Xaluritamig | Up to approximately 24 months |
| Time to Cmax (Tmax) of Xaluritamig | Up to approximately 24 months |
| Area Under the Concentration-time Curve (AUC) Over the Dosing Interval of Xaluritamig | Up to approximately 24 months |
| Terminal Half-life (t1/2) of Xaluritamig | Up to approximately 24 months |
Countries
Australia, United States
Contacts
STUDY_DIRECTORMD
Amgen
Outcome results
None listed